Glycerides, C16-18

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Skin sensitisation

A study was conducted to determine the skin sensitisation potential of ‘Glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) in guinea pigs according to the Buehler method. An occlusive Webril pad containing 0.5 mL of 5% substance in ethyl alcohol was applied for 6 h to the shaved backs of 15 guinea pigs. This procedure was repeated three times weekly for a total of nine induction applications. A control group of 5 animals was subjected to the same treatment using only the vehicle, 95% ethyl alcohol. Two weeks after the last prechallenge application, all animals were challenged topically and skin reactions were graded after 24 h. No animals developed skin responses significantly greater than the controls. Under the test conditions, the substance was found to be nonsensitizing to guinea-pig skin (CIR, 1986).

A study was conducted to determine the skin sensitisation potential of ‘Glycerides, C8 -18 and C18 -unsatd.’ (as coconut oil) in guinea pigs using the Magnusson-Kligman maximization procedure. 10 test animals and 10 controls were used in the induction, booster, and challenge phases. Induction was done by intradermal injection of 5% the test substance with Freund’s complete adjuvant. 1 wk after induction, 5% sodium lauryl sulfate in petrolatum was applied to each induction site. 24 h later, a topical booster of 100% test substance was applied to the same sites. 2 wks after the topical booster, the animals were challenged with topical applications of 50% and 100% test substance. Sites were graded after 48 and 72 h of challenge application. Coconut oil was non-irritating and failed to produce an allergic response. Under test conditions, the test substance was found to be non-sensitizing to guinea pig skin (CIR, 1986).

A study was conducted to determine the skin sensitization potential of ‘glycerides, C16-18 and C18 -unsatd.’ (as palm oil) according to the Magnusson-Kligman maximization test, using three groups of 10 female guinea pigs of the Hartley strain. In the induction phase, the test group was injected with: 5% substance in propylene glycol, 5% substance in 50% aqueous Freund's Complete Adjuvant and 50% Freund's Complete Adjuvant. In the booster phase, the undiluted substance (0.5 mL) was applied occlusively. Two of the groups served as controls. All the groups were challenged with 0.5 mL of 5% substance. Reactions were observed 24 and 48 h after patch removal. No reactions were observed in any of the tested group. Under the test conditions, 5% substance was found to be non-sensitizing to guinea pigs (CTFA, 1978).

A study was conducted to evaluate the skin sensitisation potential of soybean oil in guinea pigs. The procedure was based on the maximisation method described by Magnusson and Kligman, 1970. Induction phase consisted of intradermal injection of 5% of the substance followed by epicutaneous application of undiluted substance. 50% of the substance was applied epicutaneously during challenge phase. 0/10 guinea pigs were sensitized after 3 challenges. Under the test conditions, the substance was determined to be a non-sensitizing to guinea pig skin (Unilever Research, 1982).

Justification for classification or non-classification

Based on evidences from guinea pig skin sensitisation tests conducted according to the Buehler or maximisation test protocol for other substances of the same read across category, no skin sensitization potential is expected.Exposure to aerosolised or powder form of this substance via the inhalation route and consequent respiratory sensitisation is not expected given the implementation of appropriate risk management measures (e.g dust filter mask) and its low vapour pressure (< 1.33 x 10^-8Pa at 20°C). Moreover, the substance is typically used in industrial applications and transported and handled in liquid form. Therefore respiratory tract sensitization will not be an issue for human health. Based on the above information, ‘glycerides, C16-18 (SDA Reporting Number: 19-001-00)’ does not require classification for sensitization according to EU CLP Regulation (EC) 1272/2008.